Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05925699

National Database of the Virtual Institute of Cerebrovascular Diseases

The primary aim of the study is to develop a national registry of cerebrovascular diseases in order to define the subtypes of these diseases associated with a worse prognosis. Secondly, the study aims to find clinical, radiological, and biological markers capable tof predicting the outcome of cerebrovascular diseases and the onset of complications related to therapeutic procedures, and to calculate predictive prognostic scores composed of multiple variables.

Each participating center will collect clinical, radiological, and biological data from the medical records of the study participants. Patients included in the study will not undergo any additional medical procedures to those of normal clinical practice.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cerebrovascular Disease Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of cerebrovascular pathology defined according to the NINDS special report of 1990 as "all disorders in which there is an area of the brain transiently or permanently affected by ischemia or bleeding and/or in which one or more blood vessels of the brain are mainly altered by a pathological process", falling within the following codes of the International Classification of Diseases, 9th revision (ICD-9): ICD-9 430-438;
  • Informed consent provided by the patient or his legal representative in the case of mental incapacity or by the parents/guardians in the case of minors.

Exclusion criteria

  • The patient, his legal representative in the case of mental incapacity or his parents/guardians in the case of minors clearly state their will to leave the study;
  • Onset of cerebrovascular disease before January 1, 2016.

Treatment and study plan

Collection of clinical, radiological, and biological data from patients' medical records

Other

Collection of clinical, radiological, and biological data from patients' medical records

Primary outcomes

  1. Identification of subtypes of each cerebrovascular disease (ICD-9 430-438) associated with poor prognosis.

    Time frame: July 1, 2023 - July 1, 2053

    Identification and definition of the various subtypes of each cerebrovascular disease (International Classification of Diseases, 9th revision (ICD-9): ICD-9 430-438) associated with poor prognosis.

Secondary outcomes

  1. Identification of clinical variables of each cerebrovascular disease correlated with its prognosis

    Time frame: July 1, 2023 - July 1, 2053

    Identification of the clinical variables of each cerebrovascular disease correlated with its prognosis

  2. Identification of radiological variables of each cerebrovascular disease correlated with its prognosis

    Time frame: July 1, 2023 - July 1, 2053

    Identification of the radiological variables of each cerebrovascular disease correlated with its prognosis

  3. Identification of biomarkers of each cerebrovascular disease correlated with its prognosis

    Time frame: July 1, 2023 - July 1, 2053

    Identification of the biomarkers of each cerebrovascular disease correlated with its prognosis

  4. Identification of neurophysiological variables of each cerebrovascular disease correlated with its prognosis

    Time frame: July 1, 2023 - July 1, 2053

    Identification of the neurophysiological variables of each cerebrovascular disease correlated with its prognosis

  5. Identification of prognostic scores for each cerebrovascular disease

    Time frame: July 1, 2023 - July 1, 2053

    Identification of prognostic scores for each cerebrovascular disease, based on the combination of clinical, radiological, neurophysiological and biomarker variables

  6. Identification of clinical variables of each cerebrovascular disease helping in differential diagnosis

    Time frame: July 1, 2023 - July 1, 2053

    Identification of clinical variables of each cerebrovascular disease that help the clinician in early differential diagnosis

  7. Identification of clinical variables of each cerebrovascular disease capable of predicting the development of complications

    Time frame: July 1, 2023 - July 1, 2053

    Identification of clinical variables of each cerebrovascular disease capable of predicting the development of spontaneous complications or complications related to therapeutic procedures

  8. Identification of clinical variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies

    Time frame: July 1, 2023 - July 1, 2053

    Identification of clinical variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies

  9. Identification of the clinical variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome

    Time frame: July 1, 2023 - July 1, 2053

    Identification of the clinical variables of each cerebrovascular disease useful for the purpose of personalizing the rehabilitation treatment and able to predict the good functional outcome following the same rehabilitation treatments

  10. Identification of neurophysiological variables of each cerebrovascular disease helping in differential diagnosis

    Time frame: July 1, 2023 - July 1, 2053

    Identification of neurophysiological variables and biomarkers of each cerebrovascular disease helping in differential diagnosis

  11. Identification of radiological variables of each cerebrovascular disease helping in differential diagnosis

    Time frame: July 1, 2023 - July 1, 2053

    Identification of radiological variables of each cerebrovascular disease helping in differential diagnosis

  12. Identification of neurophysiological variables of each cerebrovascular disease capable of predicting the development of complications

    Time frame: July 1, 2023 - July 1, 2053

    Identification of neurophysiological variables of each cerebrovascular disease capable of predicting the development of complications

  13. Identification of radiological variables of each cerebrovascular disease capable of predicting the development of complications

    Time frame: July 1, 2023 - July 1, 2053

    Identification of radiological variables of each cerebrovascular disease capable of predicting the development of complications

  14. Identification of biomarkers of each cerebrovascular disease helping in differential diagnosis

    Time frame: July 1, 2023 - July 1, 2053

    Identification of biomarkers of each cerebrovascular disease helping in differential diagnosis

  15. Identification of biomarkers of each cerebrovascular disease capable of predicting the development of complications

    Time frame: July 1, 2023 - July 1, 2053

    dentification of biomarkers of each cerebrovascular disease capable of predicting the development of complications

  16. Identification of biomarkers of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies

    Time frame: July 1, 2023 - July 1, 2053

    Identification of biomarkers of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies

  17. Identification of radiological variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies

    Time frame: July 1, 2023 - July 1, 2053

    Identification of radiological variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies

  18. Identification of the radiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome

    Time frame: July 1, 2023 - July 1, 2053

    Identification of the radiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome

  19. Identification of the neurophysiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome

    Time frame: July 1, 2023 - July 1, 2053

    Identification of the neurophysiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome

  20. Identification of the biomarkers of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome

    Time frame: July 1, 2023 - July 1, 2053

    Identification of the biomarkers of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Irene Scala

CONTACT

[email protected]

+393519746393

Paolo Calabresi, Prof, MD

CONTACT

[email protected]

+390630154459

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Fondazione Don Carlo Gnocchi ETS
  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  • Fondazione IRCCS Policlinico San Matteo di Pavia
  • Fondazione IRCCS San Gerardo dei Tintori
  • Humanitas Hospital, Italy
  • I.R.C.C.S. Fondazione Santa Lucia
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • IRCCS Centro Neurolesi Bonino Pulejo
  • IRCCS Fondazione Stella Maris
  • IRCCS National Neurological Institute "C. Mondino" Foundation
  • IRCCS San Camillo, Venezia, Italy
  • IRCCS San Raffaele Roma
  • Istituti Clinici Scientifici Maugeri SpA
  • Istituto Auxologico Italiano
  • Istituto Di Ricerche Farmacologiche Mario Negri
  • Istituto Neurologico Mediterraneo Neuromed S. R. L
  • Ospedale Pediatrico Bambin Gesù
  • Ospedale Policlinico San Martino
  • Ospedale San Raffaele

Registry information

Acronym: BIG-MENTI

Important dates

Study start
2023
Primary completion
2052
Study completion
2052
First posted
Jun 29, 2023
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.